MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE; INSTRUMENT, BIOPSY

Model Number MST0812

Device Problems Suction Problem (2170); Failure to Obtain Sample (2533)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

Event Description

Mammotome stereotactic probe-during stereotactic biopsy vacuum would not suction properly.Biopsy device removed and replaced with new one.Procedure successfully completed.

• Brand Name: MAMMOTOME REVOLVE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 17236948
• MDR Text Key: 318215076
• Report Number: 17236948
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MST0812
• Device Catalogue Number: MST0812
• Device Lot Number: F12308401D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2023
• Date Report to Manufacturer: 06/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA